New route of administration provides greater convenience and choice for physicians and patients

TORONTO, March 15, 2012 /CNW/ – Janssen Inc. announced today that Health Canada has approved an expanded indication for VELCADE® (bortezomib) to include subcutaneous administration in the treatment of multiple myeloma, a form of blood cancer.1,2 this route of administration was studied in patients with relapsed multiple myeloma. with this approval, Canadians living with multiple myeloma can now receive a convenient, subcutaneous (under the skin) injection that allows for greater physician and patient treatment choice.3 VELCADE® was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of multiple myeloma patients who have relapsed following front-line therapy and are refractory to their most recent therapy. In 2008, VELCADE® was also approved as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation.

"the new option of the subcutaneous delivery route has the potential for more patients to benefit from bortezomib. Patients with poor venous access will have improved convenience. For patients with pre-existing peripheral neuropathy and patients at high risk for developing peripheral neuropathy this alternate route will also result in improved safety with the reduced risk of developing worsening of neuropathy," said Dr. Kevin Song, MD, FRCPC, BC Cancer Agency, Vancouver General Hospital and the Leukemia/Bone Marrow Transplant Program of BC, Vancouver. "In addition, subcutaneous delivery of bortezomib provides physicians and patients the opportunity to tailor treatment based on individual preferences and circumstances. I have no doubt that the subcutaneous delivery route will become the preferred option."

Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow.4 Symptoms of the disease often include bone pain, fatigue, unusual bleeding (usually from the nose and gums), frequent infections and fevers, thirst, weight loss and nausea or vomiting. Multiple myeloma may also cause structural bone damage resulting in painful fractures.5 the goal of multiple myeloma treatment is to relieve symptoms, avoid complications, and prolong life.6

"Myeloma Canada endorses Health Canada's decision to approve the subcutaneous administration of VELCADE®," said Aldo Del Col, Co-Founder and Executive Director of Myeloma Canada. "From a patient perspective, subcutaneous administration may reduce the risk of neuropathy, thereby allowing patients to continue their treatment to optimize clinical outcomes."

The results of an open-label, randomized, phase III non-inferiority study1 conducted with 222 patients with relapsed multiple myeloma randomly assigned to receive subcutaneous or intravenous bortezomib found that patients receiving bortezomib subcutaneously achieved a four-cycle overall response (ORR) of 42 per cent and complete response (CR) rate of six per cent, while patients receiving bortezomib intravenously achieved an ORR of 44 per cent and a CR rate of nine per cent. the overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, six per cent of patients experienced PN of grade three or higher, compared with 16 per cent in the intravenous arm. In the subcutaneous arm, 38 per cent of patients experienced PN of all grades, compared with 53 per cent of patients in the intravenous arm. Dose reductions occurred due to drug related adverse events in 31 per cent of patients in the subcutaneous treatment group compared with 43 per cent of the intravenously treated patients.7 In the subcutaneous treatment group, 18 per cent of patients discontinued study treatment due to a drug-related adverse event compared with 23 per cent in the intravenous treatment group.8

"this new indication further supports the efficacy of bortezomib for patients living with multiple myeloma," added Dr. Song. "In addition, subcutaneous delivery may offer greater convenience to patients and healthcare providers."

About Multiple Myeloma in CanadaMultiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma.9 In 2011, there were approximately 7,000 Canadians living with multiple myeloma and the prevalence in Canada continues to rise.1 according to the 2011 Canadian Cancer Statistics report released by the Canadian Cancer Society, the total new cases of multiple myeloma diagnosed annually in Canada are estimated at 2,300, with the total number of deaths from multiple myeloma estimated at 1,370 annually.8 the average age at diagnosis is 62 years for men and 61 years for women, and only four per cent of cases are diagnosed in individuals under the age of 45.11

About VELCADE® (bortezomib) for Injection1VELCADE® offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. by blocking the proteasome, VELCADE® disrupts processes related to the growth and survival of cancer cells. the proteasome is a structure that exists in all cells and plays an important role in breaking down proteins that control how the cell lives and grows.

VELCADE® was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of patients with multiple myeloma who have relapsed following front-line therapy and are refractory to their most recent therapy.

VELCADE® was also approved in June 2008 for the treatment of patients with mantle cell lymphoma (MCL), who have relapsed or are refractory to at least one prior therapy. MCL is a type of non-Hodgkin's lymphoma, which is a cancer of the blood that affects the white blood cells.

VELCADE® is approved in more than 90 countries and has been used to treat more than 300,000 patients worldwide.

VELCADE® Safety Information1 VELCADE® is approved as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation and for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have undergone or are unsuitable for stem cell transplantation. VELCADE® is also approved for the treatment of patients with mantle cell lymphoma (MCL), who relapsed or are refractory to at least one prior therapy.

VELCADE® must be administered under the supervision of a physician qualified in the use of anti-cancer drugs.  VELCADE® is contraindicated in patients with hypersensitivity to bortezomib, boron or any of the excipients. VELCADE® should not be administered intrathecally. Fatal events have occurred with intrathecal administration of VELCADE®.

Serious side effects that may occur with VELCADE® include: low blood pressure and other serious heart disorders; bleeding into the brain or gastrointestinal tract (stomach or bowel); muscle weakness due to nerve damage (severe motor neuropathy); and acute lung disease (acute diffuse infiltrative pulmonary disease). Both men and women must use effective contraception while receiving VELCADE®, and for three months after their treatment. Women should be advised not to take VELCADE® while pregnant or breast-feeding.

The safety and effectiveness of VELCADE® in children and adolescents (<18 years of age) have not been established.

These are not all of the possible side effects with VELCADE®. Please refer to the VELCADE® product monograph complete prescribing information including contraindications available at janssen.ca.

About Janssen Inc. As a member of the Janssen Pharmaceutical Companies, Janssen Inc. is dedicated to addressing and solving the most important unmet medical needs in pain management, psychiatry, oncology, immunology, psoriasis, virology, anemia, attention deficit hyperactivity disorder, gastroenterology and women's health. Driven by our commitment to the passionate pursuit of science for the benefit of patients, we work together to bring innovative ideas, products and services to patients around the world.

*All trademark rights used under license.

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1 VELCADE® Product Monograph. Available at: janssen.ca2 Canadian Cancer Society.  Canadian Cancer Encyclopedia. info.cancer.ca/cce-ecc/default.aspx?cceid=1478&toc=29&Lang=E3 Moreau MMY3021 Mateos Commentary Lancet Oncology, Published online April 19, 2011. Available at: thelancet.com/oncology4 Canadian Cancer Society, What is multiple myeloma? Available at: cancer.ca/Canada-wide/About%20cancer/Types%20of%20cancer/What%20is%20multiple%20myeloma.aspx?sc_lang=enLast accessed on February 28, 2012.5 Canadian Cancer Society. Signs and Symptoms of Multiple Myeloma. Available at: cancer.ca/Canada-wide/About%20cancer/Types%20of%20cancer/Signs%20and%20symptoms%20of%20multiple%20myeloma.aspx?sc_lang=en Last accessed on February 28, 2012.6 PubMed Health. Multiple myeloma. Available at: ncbi.nlm.nih.gov/pubmedhealth/PMH0001609/ Last accessed on February 28, 2012.7 VELCADE® Product Monograph. Available at: janssen.ca. Page 20.8 VELCADE® Product Monograph. Available at: janssen.ca. Page 20.9 Myeloma Canada. About Myeloma. Available at: myelomacanada.ca/en/aboutmyeloma.htm  Last accessed on February 28, 2012.10 Canadian Cancer Society. Canadian Cancer Statistics 2011 report. Available at: cancer.ca/Canada-wide/About%20cancer/~/media/CCS/Canada%20wide/Files%20List/English%20files%20heading/PDF%20-%20Policy%20-%20Canadian%20Cancer%20Statistics%20-%20English/Canadian%20Cancer%20Statistics%202011%20-%20English.ashx Last accessed on February 28, 2012.11 Myeloma Canada. Incidence and Prevalence of Myeloma in Canada. Available at: myelomacanada.ca/en/incidence_prevalence.htm Last accessed on February 28, 2012